There is a good deal of evidence that cognitive behavioural therapy is effective for children and adolescents with anxiety-related problems. In Japan, an anxiety prevention programme based on cognitive behavioural therapy called ‘Journey of the Brave’ has been developed, and it has been demonstrated to be effective for elementary school students (aged 10–11 years).
Trang 1RESEARCH ARTICLE
A pilot and feasibility study of a cognitive
behavioural therapy-based anxiety prevention programme for junior high school students
in Japan: a quasi-experimental study
Ikuyo Ohira1,2* , Yuko Urao1,2, Yasunori Sato3, Toshiyuki Ohtani1,4 and Eiji Shimizu1,2,5
Abstract
Background: There is a good deal of evidence that cognitive behavioural therapy is effective for children and
ado-lescents with anxiety-related problems In Japan, an anxiety prevention programme based on cognitive behavioural therapy called ‘Journey of the Brave’ has been developed, and it has been demonstrated to be effective for elementary school students (aged 10–11 years) The purpose of this study was to have classroom teachers deliver the programme
to junior high school students (aged 12–13 years) and to test the feasibility and efficacy of the programme in this setting
Methods: This study was a prospective observational study and was approved by the Chiba University Review Board
An intervention group consisting of six classes of students in their first year of junior high school at two different
schools (n = 149; 81 boys, 68 girls) received seven 50-min programme sessions Participants in the control group were recruited from four classes of students in their second year of junior high school at one school (n = 89; 51 boys, 38
girls) All participants completed the Spence Children’s Anxiety Scale at pre-test, post-test, and 2–3 month follow-up Statistical analysis was conducted using a mixed-effects model for repeated measures model
Results: Mean total anxiety scores indicated a non-significant decrease at the 2–3 month follow-up for the
interven-tion group compared to the control group The group differences on the SCAS from baseline to post-test was − 71
(95% CI − 2.48 to 1.06, p = 43), and the 2–3 month follow-up was − 49 (95% CI − 2.60 to 1.61, p = 64).
Conclusions: In this pilot study, implementation of the programme confirmed the partial feasibility of the
pro-gramme but did not elicit a significant reduction in anxiety scores In addition, there are several methodological limitations to this study In the future, we propose to test the feasibility and efficacy of the programme with the required sample size and by comparing groups with equal characteristics as well as by carrying out additional
follow-up assessments
Trial registration UMIN000032517.
Keywords: Anxiety, Prevention, Cognitive behavioural therapy, Junior high school, Universal, Japan
© The Author(s) 2019 This article is distributed under the terms of the Creative Commons Attribution 4.0 International License ( http://creativecommons.org/licenses/by/4.0/ ), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/ publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
Open Access
*Correspondence: sunny133888@gmail.com
1 United Graduate School of Child Development, Osaka University,
Kanazawa University, Hamamatsu University School of Medicine,
Chiba University and University of Fukui, 2-2 Yamadaoka, Suita-shi,
Osaka 565-0871, Japan
Full list of author information is available at the end of the article
Trang 2Anxiety disorders are one of the most common types of
psychiatric disorder [1], with the lifetime prevalence of
any anxiety disorder in children and adolescents ranging
from 8.8 to 31.9% The average age of onset for anxiety
disorders is 11 years [2], and such disorders are likely to
become chronic [3] It is believed that anxiety often leads
to depression; for example, according to the results of a
follow-up survey conducted 10 years after a
longitudi-nal study of anxiety and depressive disorders in
adoles-cents, anxiety disorder in adolescents is associated with
a relatively high risk of anxiety or depressive disorders in
adulthood [4] In Japan, a study examining the
relation-ship between anxiety and depression among junior high
school students found a significant longitudinal
relation-ship between these disorders after 3 months [5] Thus,
the symptoms of many anxiety disorders are chronic, and
anxiety has been found to increase the risk of depression
and other psychiatric disorders
Anxiety disorders in children and adolescents
inter-fere with their school life; for example, it has been
shown that they result in school refusal and a decline in
academic performance [6 7] The results of a previous
study of school refusal among adolescents indicate that
this is often caused by anxiety disorders Anxiety
disor-ders are observed in approximately 50% of individuals in
representative samples of clinic-referred youth
exhibit-ing school refusal [8] Particularly, in Japan, it has been
pointed out that the problem of school refusal is strongly
related to anxiety According to a survey conducted by
the Ministry of Education, Culture, Sports, Science and
Technology in 2017 [9], the number of school
refus-als among elementary and junior high school students
is more than 140,000, representing a higher proportion
of the population than previously seen It has also been
reported that the proportion of students with tendencies
to anxiety is up to 33.2%, which is a contributing factor to
this state of affairs
The relationship between anxiety and academic
achievement has also been studied In recent years,
the relationship between developmental disorders and
school maladaptation has attracted much attention;
how-ever, there is a possibility that children and adolescents
who have difficulty concentrating or paying attention in
school as a result of anxiety problems tend to be
misdi-agnosed as having attention deficit hyperactivity
disor-der (ADHD) [10] Furthermore, it has also been pointed
out that children diagnosed with a learning disability
or ADHD include those who show poor performance
because of high anxiety [11] As mentioned above, it
has been shown that anxiety problems among children
and adolescents cause maladaptation to school life, and
in turn, this maladaptation may later become a factor
in other comorbidities, such as anxiety disorders and depression Therefore, it is important to provide early preventive interventions for children and adolescents with the aim of preventing anxiety problems
Although support during adolescence is regarded as important, many adolescents who have anxiety do not receive appropriate support [12] In addition, in many cases, it takes a considerable amount of time for patients
to begin receiving treatment after the onset of a disorder [13] A lack of knowledge about mental health and the stigma attached to mental health problems are consid-ered factors in this delay in obtaining support; acquiring accurate knowledge about mental health in school classes
is effective in preventing such delays [14] Puberty, also referred to as ‘the second birth’ [15], is regarded as a developmental stage during which individuals are par-ticularly sensitive to others’ evaluations of them, in addi-tion to being a period of remarkable mental and physical development; thus, it is also a period during which vari-ous emotional and behavioural problems become more likely [16] It is reported that adolescents may present with more severe forms of anxiety-based school refusal than do younger children, and in adolescents, this is also more frequently associated with depressive disorders [17] It is clear that the presence of an anxiety disorder
in this age group is a high-risk factor for serious mental health problems, and support must be offered to children and adolescents in an effective and accessible form [18] Cognitive behavioural therapy (CBT) is an evidence-based psychological treatment method that can alleviate and improve emotional problems such as anxiety and depression School-based treatment programmes based
on CBT for anxiety, depression, and other problems in children have been found to be effective in randomised controlled trials [19] Furthermore, attention has been paid to a CBT-based approach to anxiety prevention, which has been found to be effective when delivered in schools [20]
Preventive interventions for mental disorders are clas-sified into three levels by the Institute of Medicine (IOM): (1) universal interventions, (2) selective interventions, and (3) indicated interventions [21] Universal interven-tions target the whole population, including those who have no symptoms of the relevant disorder Selective interventions target individuals or groups who are at a higher than average risk Lastly, indicated interventions target individuals or groups who are already experiencing
a low-to-moderate level of symptoms, and therefore, are
at a high risk of developing the disorder in the future For students, school is a natural and familiar place, and the implementation of a universal prevention programme
in schools enables students to receive treatment more easily in terms of time, place, and cost, and may provide
Trang 3them with skills and strategies that help prevent or delay
the onset of mental disorders [22–24] Therefore, it can
be argued that it is of great importance to implement a
universal prevention programme to prevent future
anxi-ety disorders and to reduce the risk of comorbidity, even
in children without particular symptoms or signs at the
time of the intervention Although the delivery of a
men-tal health programme in school by class teachers has
an especially low cost, which makes continued
imple-mentation of such a programme possible, the results of
a randomised controlled trial of a universal prevention
programme for anxiety in school did not demonstrate
the effectiveness of the teacher’s conduct [25]; however,
other randomised controlled trials have found that in the
trauma-focused group intervention ‘Mein Weg’ for young
refugees, lay counsellors’ conduct in a psychosocial
intervention was effective [26, 27] As mentioned above,
numerous benefits of implementing the programme at
the school exist, and we believe that it would be
benefi-cial for the teacher to participate in this programme
‘Friends’ is a universal programme aimed at preventing
childhood and adolescent anxiety [28] This programme
has been shown to be effective in adolescents (aged
14–16 years), although the effect of the intervention on
this group is small compared to its effect on younger
chil-dren (aged 9–10 years) [29] However, implementation of
the ‘Friends’ programme in Japan did not lead to a
sig-nificant reduction in total anxiety scores [30] Therefore,
it might be effective to apply a programme developed
according to the social and cultural background of Japan
In Japan, a CBT-based anxiety prevention programme
called ‘Journey of the Brave’ that can be implemented as
part of the Japanese school curriculum has been
devel-oped [31] In a previous study on fifth year elementary
school students (intervention group n = 41, control group
n = 31), trained health facilitators (with graduate school
training in CBT) conducted 10 sessions in the
class-room as a school lesson [32] The mean anxiety score on
the SCAS for the intervention group had significantly
reduced at both post intervention and the 3-month
fol-low-up compared to the control group
Although research into this topic targeting junior high
school students have not so far been conducted in Japan,
we believe that it is important to tackle potential mental
health problems in junior high school students, given that
as described above, they may face an ‘adolescent crisis’ at
a mentally and physically sensitive stage of their life
Furthermore, in Japan, the first year of junior high
school is also the year in which students experience
major changes in their educational environment First,
as multiple elementary schools feed into each junior
high school, the school and its classes are larger in size,
and students experience major changes in their peer
relationships Second, elementary school and junior high school differ greatly in terms of the student–teacher rela-tionship In elementary school, the so-called ‘home room teacher’ system is applied, while the junior high school follows the curriculum management system (different areas of the curriculum are taught by specialised teach-ers) Finally, the number of subjects and the degree of learning difficulty increase In addition to experiencing such environmental changes, researchers have pointed out that junior high school students are also approach-ing a sensitive stage of adolescence, durapproach-ing which various psychological and behavioural problems may come to the surface [33]
The ‘Journey of the Brave’ programme was originally developed for children in the fourth to sixth year of elementary school However, because the programme was designed based on evidence-based CBT theory and tackles ways to cope with anxiety in interpersonal rela-tionships, it seems likely that this programme could
be adapted for use among junior high school students Therefore, in this pilot study, we aimed to implement this programme among junior high school students, with the classroom teacher acting as a facilitator, and to test its feasibility and efficacy with the aim of preventing anxiety problems
Methods
Study design and participants
This study was conducted in collaboration with Chiba University and Kodomo Minna Project (‘Project for all the children’) This is a project in which ten universities collaborated and conducted a research, commissioned by the Ministry of Education, Culture, Sports, Science and Technology, for the purpose of improving school refusal and bullying, which are major issues in Japanese schools This is part of a research project on students from ele-mentary to high school In this study, data on junior high school students were collected and analysed The Minis-try of Education, Culture, Sports, Science and Technol-ogy recruited schools to participate in this programme The Board of Education of a prefecture located in the western part of Japan applied to participate, and students
in their first year of junior high school were selected to participate in the programme Although it would have been desirable methodologically to recruit a control group from students in the same year, the Board of Edu-cation made a firm request for all first-year students in the participating schools to receive the programme at the same time; therefore, students in their second year of junior high school were recruited for the control group This was a universal quasi-experimental study with an intervention and a control group The participants in the study were 472 students in their first or second year of
Trang 4junior high school (aged 12–14 years), attending three
public junior high schools in a single prefecture in Japan
Intervention group participants received the anxiety
prevention programme, and control group participants
received no prevention programme
In addition, the ‘Journey of the Brave’ programme was
conducted as part of regular classes in schools This study
was a prospective observational study that collected and
analysed students’ anxiety scores before and after the
programme It was approved by the Chiba University
Review Board In this study, consent was obtained in the
form of an opt-out Parents were given an informational
letter about the study, and they could provide opt-out
consent to exclude their child from participation In
addi-tion, at the time of the survey, teachers distributed a
writ-ten assent form for the students, for students to provide
their assent to participate
Prevention programme: ‘Journey of the Brave’
Table 1 provides a summary of the ‘Journey of the
Brave’ programme This is a programme developed with
consideration for the psychological characteristics of
children and adolescents and for the social and cultural
background of Japan, with the following three
repre-sentative features [31] First, this programme
special-ises in the prevention of anxiety-related problems, to
help children and adolescents understand the purpose
of the programme and engage in effective learning
Second, in order to enable children and adolescents to
enjoy the programme, likeable characters are presented
in a story format Third, group work is intentionally
avoided in favour of emphasising an individual work
format because of the psychological characteristics of
Japanese adolescents It has been pointed out that
com-pared to individuals in Western countries, Japanese
individuals tend to be more influenced by the way they
are perceived by others [34] Adolescents tend to feel more anxious about the relationships within the same age group [35], and it is necessary to consider that there may be some students with high anxiety in the class This programme consists of ten 45-min sessions; the content is taught according to a workbook and a teacher’s manual The first half of the programme is dedicated to the development of ‘anxiety hierarchy’ and the experience of gradual exposure, while the sec-ond half mainly concerns cognitive restructuring More precisely, after psychological education on anxious feelings (i.e., the notion that anxiety is a natural feel-ing that everybody has and plays an important role in protecting you from danger, but if excessive anxiety persists, it might lead to disturbances in life, etc.), each student is encouraged to establish his or her own goal for the programme, such as giving a presentation in front of all the students, an important test, and so on
In stage 3, relaxation skills such as breathing methods and muscle relaxation are taught In stage 4, students develop a table of their ‘anxiety hierarchy’, consisting
of 7 steps that will allow them to reach the goal set in stage 2 Stages 5, 6, and 7 encompass the process of gradually learning about the cognitive model (the rela-tionship between cognition, behaviour, emotion, and bodily responses) as well as cognitive restructuring
At the same time, gradual exposure homework is given
to address higher levels of anxiety in accordance with the anxiety stairs table developed in stage 4 Assertion skills to reduce interpersonal anxiety are taught in stage 8; stage 9 consists of an overall review session; and stage 10 involves a summary and graduation ceremony
In the workbook used by the students, realistic exam-ples of many anxiety-provoking moments in their daily lives are provided so that they can deepen their under-standing of anxious feelings and CBT
Table 1 Contents of ‘Journey of the Brave’ by session
Session at the junior high school Original session Content of ‘Journey of the Brave’
6 Identifying cognitive distortions and coping with rumination
Trang 5The original ‘Journey of the Brave’ programme consisted
of 10 sessions (administered once per week, each lasting
45 min) As this study conducted the programme in
jun-ior high schools, the research group elected to reduce the
number of sessions in view of the fact that the length of
class time was 5 min longer than in elementary school,
and that junior high school students should be able learn
more quickly In addition, since the curriculum of the
regular classes for the year has already been determined,
the Board of Education requested that the number of
classes be reduced to seven that were administered about
once per week and lasting 50 min
In this programme, the content of each session was
based on CBT theory (Table 1), but the relaxation
method (Stage 3) could be shortened as it was addressed
in health class, and Stages 2 and 3 were consolidated into
one session The remaining content was implemented
within the 7 class hours As Stages 5 and 6 as well as
Stages 9 and 10 had little individual work for students, we
decided to summarize these in one session
Additionally, the following three things were addressed
as we utilized a group of practitioners who did not have
specialized knowledge about CBT to allow them to lead
this programme smoothly and effectively First, we
con-ducted a 6-h workshop, which was a training course This
training course was a free workshop, and participants
received a certificate of completion This workshop
con-sists of lectures on the theory of CBT, role-plays for each
session (lasting about 20 min per session), feedback from
instructors, and time for questions and answers
Sec-ond, we devised a workbook with detailed contents that
allowed the students to read and understand it
them-selves Third, we had them utilize a teacher’s manual,
which was distributed to the teachers The teacher’s
man-ual was attached with the Q & A and information on how
to proceed with the class, which was created based on
questions by teachers in past programmes In addition,
after the completion of stage 3, a template for reporting
the progress of the class was attached to the teacher’s
manual In the report template, there is a field for
com-ments and consultations for supervision In addition, if
the teachers wanted to have a consultation, they could do
so at any time by phone or email during the intervention
period This was described in the manual and shared with
the teachers at the workshop
The preventive interventions were conducted from
September to November 2017 in one participating school
and from October to December 2017 in the other In each
case, the intervention was delivered by the class teacher,
who had taken the ‘Journey of the Brave’ programme
instructor training course In total, the programme was
implemented by the class teacher in six classes of two junior high schools
All sessions were held in the classroom during regular class time Every session was conducted according to the workbook and the teacher’s manual, and a piece of home-work was to be assigned at the end of each session, to be worked on at home and returned by the next session, in order to help students consolidate the content Students
in the control group followed the regular school curricu-lum The main assessments were a pre-test (Time 1; base-line), a post-test (Time 2; 2–3 months after basebase-line), and
a follow-up test (Time 3; 2–3 months after the post-test)
At each of these time points, self-report questionnaires were distributed to the students by the teacher in charge
of each class, and all students (149 in the intervention group and 89 in the control group) completed the ques-tionnaires The teachers assisted students in this process
by reading the questions aloud
Measurements
Primary outcome measure: Spence Children’s Anxiety Scale
The Spence Children’s Anxiety Scale (SCAS) [36] is a self-report measure of anxiety symptoms designed for children and adolescents The scale consists of 38 items relating to anxiety symptoms, divided into six subcat-egories: separation anxiety, social phobia, panic disorder/ agoraphobia, generalised anxiety disorder, fear of physi-cal injury, and obsessive–compulsive disorder Possible
item scores range between 0 (never) and 3 (always), and
the maximum possible score is 114 Ishikawa et al [37] developed a Japanese version of the SCAS with good internal reliability coefficients According to a previous study, the average SCAS score among 7- to 19-year-old
children and adolescents is 18.11 (SD = 12.87), and the
cut-off point is 35 [38]
Secondary outcome measure: Emotion‑Regulation Skills Questionnaire
The Emotion-Regulation Skills Questionnaire (ERSQ) [39] is a self-report questionnaire consisting of 27 items
Possible item scores range between 0 (not at all) and 4 (almost always), and the maximum possible score for
the questionnaire is 108 In the original version, success-ful application of emotion-regulation skills is assessed through the following nine subscales: awareness, sensa-tion, clarity, understanding, modificasensa-tion, acceptance, tolerance, readiness to confront, and compassionate self-support Fujisato et al [40] developed a Japanese version of the ERSQ with good internal reliability coeffi-cients In the Japanese version, items are divided into two subcategories: acceptance and engagement (tolerance, modification, readiness to confront, and acceptance)
Trang 6and awareness and understanding (sensation, awareness,
understanding, clarity, and compassionate self-support)
Programme evaluation form for students
Students were asked to evaluate the programme after
completing all seven sessions An evaluation form was
used to measure their acceptance of and satisfaction with
the programme The form comprised the following two
sections: (1) the student’s evaluations of the content of
the programme (5 items; for example, ‘Do you think that
this programme helped you to cope well with your
feel-ings of anxiety?’ with each item scored from 0 = disagree
to 3 = agree; see Additional file 1: Table S1) and (2) the
student’s accomplishment of their ‘anxiety hierarchy’ task
(scored from 0 = none to 3 = complete).
Statistical analysis
For baseline variables, summary statistics are presented
in the form of frequencies and proportions for
categori-cal data, and means and SDs for continuous variables
Analysis of the primary outcome measure consisted of
a mixed-effects model for repeated measures (MMRM),
with intervention group, time, and the interaction
between intervention group and time as fixed effects; an
unstructured covariate was used to model the
covari-ance of within-participant variability MMRM analysis
assumes that any missing data occur randomly Analysis
of the secondary outcome measure was performed in the
same manner We also conducted subgroup analysis by
comparing the intervention and control groups on their
SCAS scores in a high-anxiety subgroup (SCAS score of
35 points or above in the pre-test) and a low-anxiety
sub-group (SCAS score below 35 in the pre-test) Subsub-group
analysis was also performed in the same manner
Additionally, the responses to the students’ evaluation
questionnaires were aggregated A repeated-measures
analysis of variance (ANOVA) was conducted to examine
the changes in SCAS scores at each time point according
to the students’ responses regarding the extent to which
they had accomplished their ‘anxiety hierarchy’ task
(0 = none to 3 = complete)
All comparisons were planned and all p values reported
are two-tailed A p value < 05 was considered to
repre-sent statistical significance All statistical analyses were
performed using the SAS software program, version 9.4
(SAS Institute, Cary, NC, U.S.A.), and SPSS Version 24.0
(IBM, Armonk, New York, USA)
Results
Three schools agreed to participate in this study, but
one was excluded from participation before the
base-line assessments because it could not deliver the full
programme during the requisite school year As a result
of confirming parental consent and the student’s par-ticipation in this research, five parents in intervention group and five parents in control group did not provide consent All students assented to participate Thus 253
of 263 eligible students at two junior high schools had valid consent to participate The intervention group consisted of first-year students (aged 12–13 years) in six classes of two junior high schools The control group consisted of second-year students (aged 13–14 years) in four classes of one junior high school The final number
of participants entered into the analysis was 149 in the intervention group (81 boys, 68 girls) and 89 in the con-trol group (51 boys, 38 girls; Fig. 1)
Pearson’s correlation coefficient indicated that there was a weak negative correlation between SCAS and
ERSQ scores at pre-test, r = − 19, p < 001 Next, the
intervention group and control group were tested for differences in gender ratio at pre-test using the Chi squared test There was no significant difference
(p = 66) Finally, t tests were conducted to compare the
groups at baseline on their pre-test SCAS and ERSQ scores The intervention group exhibited higher SCAS
scores than those of the control group (p = 02)
How-ever, there were no significant differences in ERSQ
scores between the two groups (p = 61).
Tables 2 3 4 present the results of the MMRM analy-sis of the intervention and control groups’ SCAS and ERSQ scores at each time point In the primary analysis
of SCAS scores, the estimated mean changes in SCAS score between baseline and follow-up according to the model were − 2.20 (95% CI − 3.49 to − 91) and − 1.70 (95% CI − 3.37 to − 05) for the intervention and con-trol groups, respectively; the difference between groups
was − 49 (95% CI − 2.60 to 1.61, p = 64; Table 2)
In the secondary analysis, the estimated mean changes in ERSQ score between baseline and
follow-up according to the model were 2.13 (95% CI − 15
to 4.41) and 61 (95% CI − 2.20 to 3.42) for the inter-vention and control groups, respectively; the differ-ence between groups was 1.52 (95% CI − 2.10 to 5.14,
p = 41; Table 3)
In the subgroup analysis of the high-anxiety group (SCAS scores ≥ 35), the estimated mean changes in SCAS score between baseline and follow-up according to the model were − 3.81 (95% CI − 8.25 to 63) and 89 (95% CI
− 6.04 to 7.82) for the intervention and control groups, respectively; the difference between groups was − 4.70
(95% CI − 13.02 to 3.62, p = 26; Table 4) Additionally,
in the subgroup analysis of the low-anxiety group (SCAS scores < 35), the estimated mean changes in SCAS score between baseline and follow-up according to the model were − 1.94 (95% CI − 3.26 to − 62) and − 2.03 (95% CI
− 3.70 to − 36) for the intervention and control groups,
Trang 7respectively; the difference between groups was 09 (95%
CI − 2.05 to 2.22, p = 94; Table 4)
Students’ programme evaluations
Additional file 1: Table S1 presents the number and
per-centage of respondents giving each response to each
item on the programme efficacy section of the evaluation questionnaire
According to the repeated-measures ANOVA to exam-ine SCAS scores at each time point based on students’ responses regarding the extent to which they had accom-plished their ‘anxiety hierarchy’ task (Table 5), there was
Enrollment 3 Schools Enrolled (n = 472)
Excluded
• 1 School (n = 209)
6 classes allocated to intervention (n = 162)
• Received child assent and parental
consent (n = 157)
• Did not receive parental consent (n = 5)
4 classes allocated to control (n = 101)
• Received child assent and parental
consent (n = 96)
• Did not receive parental consent (n = 5)
Non-Random Allocation
• Completed assessment (n = 147)
• Did not complete assessment (n = 2) •• Did not complete assessment (n = 2) Completed assessment (n = 87)
• Completed assessment (n = 136)
• Did not complete assessment (n = 11) • Completed assessment (n = 84) • Did not complete assessment (n = 3)
T3: Follow-up
Analysed (n = 149) Analysis Analysed (n = 89)
• Completed assessment (n = 149)
• Did not complete assessment (n = 8) • Completed assessment (n = 89) • Did not complete assessment (n = 7)
T2: Post-test T1: Pre-test
Fig 1 displays the number of students at each time point and sample count of the ITT analysis ITT intention to treat
Table 2 SCAS scores over time
Estimated mean score on the SCAS at each time point and estimated difference in change between the groups according to a mixed effects model for repeated
measures Scores are presented in the form M (95% CI) SCAS Spence Children’s Anxiety Scale
(n = 149) Control group(n = 89) Between group differences for baseline change p
Pre 21.24 (18.88–23.60) 17.40 (14.39–20.42)
Follow-up 18.86 (16.49–21.23) 15.31 (12.30–18.32) − 49 (− 2.60 to 1.61) 64
Table 3 ERSQ scores over time
Estimated mean score on the ERSQ at each time point and estimated difference in change between the groups according to a mixed effects model for repeated
measures Scores are presented in the form M (95% CI) ERSQ Emotion-Regulation Skills Questionnaire
(n = 140) Control group(n = 86) Between group differences for baseline change p
Pre 57.28 (52.89–61.68) 60.95 (55.34–66.55)
Follow-up 59.27(54.85–63.68) 61.64 (56.03–67.25) 1.52 (− 2.10 to 5.14) 41
Trang 8a no significant interaction effect between group and
time (p = 85).
Discussion
In this study, we delivered the universal anxiety
preven-tion programme ‘Journey of the Brave’ to junior high
school students in Japan and tested its feasibility and
efficacy in reducing anxiety First, none of the schools
dropped out, and all seven sessions were possible within
the schools’ curriculum In addition, the results of the
students’ responses in the evaluation questionnaire
(Additional file 1: Table S1) showed an overall positive
evaluation Thus, the feasibility of programme
imple-mentation in junior high school was partially confirmed
Next, the results indicated that there was no significant
difference between the intervention and control groups
in terms of change in SCAS scores or ERSQ scores
Fur-thermore, in a subgroup analysis, the intervention group’s
SCAS scores were not significantly reduced in either the
high-anxiety group (SCAS scores ≥ 35) or the
low-anxi-ety group (SCAS scores < 35)
In this pilot study, programme implementation did
not elicit a clear reduction in student’s anxiety, nor did
it clearly show a relationship between anxiety and emo-tional regulation skills However, there are several factors
to consider as possible reasons for the lack of reduction
in students’ anxiety in the intervention group
Student’s anxiety
The results for anxiety are in contrast to those of the original study of this preventive intervention on elemen-tary school students [32], in which a significant reduc-tion in the anxiety scores of the intervenreduc-tion group was observed We consider two possible reasons for the absence of a significant reduction in anxiety scores in the present study The first reason is that this programme was facilitated by classroom teachers with limited expertise for CBT, whereas in the original study, the programme was conducted by trained health facilitators The second
is that the environmental surroundings of junior high school students differ greatly from those of elementary school students, and the former group are at a sensitive and difficult developmental stage compared to elemen-tary school students
In the previous study with elementary school students, the programme was delivered mainly by trained health facilitators, but in the present study, the intervention was delivered by teachers In a UK-based study of the effect
of universal anxiety prevention programmes in schools,
it has been reported that intervention by trained health facilitators is effective, but that teacher-led interven-tion may not be effective [25] In this study, when class-room teachers acting as facilitators were asked about the amount of homework assigned, they reported that homework assignment and review was not practiced reg-ularly at the two schools Homework is considered one
of the most important therapeutic components of CBT [41] In CBT, the ultimate goal is for clients to be able
to exercise control over their own emotions and behav-iours, and the practice provided by homework is useful
Table 4 SCAS scores over time: subgroup
High-anxiety subgroup (SCAS scores ≥ 35), Low-anxiety (SCAS scores < 35) subgroup analysis: estimated mean score on the SCAS at each time point and estimated
difference in change between the experimental groups according to a mixed effects model for repeated measures Scores are presented in the form M (95% CI) SCAS
Spence Children’s Anxiety Scale
Pre 51.74 (46.65–56.82) 45.88 (38.04–53.72)
Post 45.80 (40.65–50.95) 46.88 (39.04–54.72) − 5.89 (− 13.71 to 1.94) 13 Follow-up 47.80 (42.47–53.14) 46.75 (38.46–55.05) − 4.70 (− 13.02 to 3.62) 26
Pre 16.76 (15.05–18.47) 13.58 (11.42–15.74)
Follow-up 14.67 (12.95–16.40) 11.81 (9.64–13.98) 09 (− 2.05 to 2.22) 94
Table 5 SCAS scores according to success in accomplishing
‘anxiety hierarchy’ task (n = 132)
SCAS scores at each time point according to the extent to which students
reported that they had succeeded in accomplishing their selected ‘anxiety
hierarchy’ exposure task Scores are presented in the form M (SD) SCAS Spence
Children’s Anxiety Scale
‘Anxiety hierarchy’ task accomplishment
(n = 15) A little(n = 52) Almost complete
(n = 56)
Complete
(n = 9)
Pre 23.87 (18.24) 22.33 (16.80) 19.34 (11.82) 14.33 (11.21)
Post 22.07 (19.27) 20.87 (15.92) 17.04 (11.30) 13.89 (13.82)
Follow-up 23.60 (20.00) 20.06 (15.93) 16.48 (12.88) 13.33 (12.53)
Trang 9in establishing knowledge and skills, making use of them
in daily life (generalisation), and improving self-efficacy
Previous studies in which this programme has been
implemented have also shown that ongoing provision
and review of homework helps students to consolidate
their knowledge and change their behaviour [32] Since
it can be presumed that the facilitator’s level of expertise
in CBT is particularly influential with regard to
home-work assignment and students’ accomplishments with
gradual exposure (reported in the present study as part
of the students’ programme evaluation questionnaires),
it is possible that differences in the expertise of
facilita-tors may have caused the disparity in effects between the
original and the present study In mental health
interven-tions delivered by lay counsellors, supervision has been
shown to be important in managing programme fidelity
[42, 43]; therefore, it will help the classes progress more
effectively if the supervision of the teachers who are
lead-ing the sessions can be enriched In this study, there were
no telephone or email consultation requests from the
teachers In addition, in the report template, the teacher
reported the completion of stage 3 and the future
sched-ule of the class at the midpoint of this programme There
was a section where comments and consultations from
teachers were entered into this report template, but there
were only comments on the programme and impressions
about the class overall, and no records of consultations
Therefore, for supervision, it will be necessary to improve
the report format so that teachers can easily complete
assignments and consultations Furthermore, in future
implementation, in addition to using the report template,
it will be important to set a time for conducting
supervi-sion sessupervi-sions in advance
In addition, the workbook used in this programme
seems to be appropriate, because it deals with themes
that are likely to present issues during adolescence, such
as anxiety in interpersonal relationships, but it is
possi-ble that the content might not have been suitapossi-ble for the
developmental stage of junior high school students
Feed-back from teachers who had been involved in delivering
this programme was collected at the end of the
interven-tion, and some teachers mentioned that ‘the illustrations
may be too childish for the students’ and ‘some examples
of anxiety scenarios don’t match the students’ level of
development’ We propose that a future task should be to
improve the content of the workbook so that it matches
the developmental stage of junior high school students
Furthermore, in the present study, the number of
ses-sions was reduced from 10 to seven in view of the fact
that junior high school students have a higher level of
understanding than elementary school students
How-ever, a meta-analysis of research on universal
school-based preventive interventions [44] shows that the
greater the number of sessions, the larger the effect; thus,
it is probable that the negative outcome in the present study may be partially attributable to this reduction of the number of sessions
We believe that the factors discussed above greatly influenced the students’ motivation for learning dur-ing this programme Therefore, it will be necessary to revise the contents of the programme further, based on the developmental stage of junior high school students and taking into account the evaluations provided by participants in the programme, and to deliver the full
10 sessions in future administrations of the preventive intervention
A final point to consider is that, in general, it is desir-able for participants in both the intervention and con-trol groups to have comparable scores on the outcome measure at baseline; however, in this study, the anxiety scale (SCAS) scores significantly differed between the groups The participants in this study were recruited from the first year (intervention group) and second year (control group) of junior high school The first year of junior high school in Japan is a year in which students experience major changes in their educational environ-ment Research has reported that school refusal and the number of students whose study motivation declines
is increasing rapidly [45] It is estimated that the first year of junior high school is a time when anxiety greatly increases compared to other grades, and the difference between the groups in this study is possibly attributable
to the fact that the groups were drawn from different academic years Additionally, the small number of par-ticipants in this study might have influenced this result The results of the original study (2018) revealed that the smaller the number of participants, the greater the dif-ference in baseline scores between the intervention and control groups In the future, we plan to verify the effi-cacy of the programme by recruiting an appropriate number of participants from the same academic year and who have comparable mean total scores on the anxiety scale (SCAS)
Students’ programme evaluations
Based on the results of the questionnaire items in which students were asked to evaluate the efficacy of the pro-gramme (item 3: ‘Do you think that this propro-gramme helped you to cope well with your feelings of anxi-ety?’ and item 5: ‘Do you think that what you learned
in this programme will be useful in the future?’), more than 70–80% of the students answered in the affirma-tive One of the advantages of implementing a univer-sal prevention programme in schools is the prevention
of potential future deterioration of the mental health
of students who do not present any symptoms or signs
Trang 10at the time of the programme, and the reduction in the
risk of other comorbidities Although no significant
reduction in participants’ SCAS scores was observed
on this occasion, we conclude that the delivery of this
programme is useful in allowing participants to acquire
knowledge and skills regarding how to manage their
anxiety, and these techniques can be used to exercise
control of their own emotions and behaviours in their
future lives By implementing this universal
interven-tion programme for anxiety preveninterven-tion in schools,
students might acquire the knowledge and skills based
on CBT and apply them to prevent mental health
dete-rioration in the future Therefore, longitudinal studies
must be conducted to verify the long-term efficacy of
universal preventive interventions [46]; doing so for
the programme implemented here, through a follow-up
assessment, is a future task
Furthermore, the results indicated that there was no
significant difference in SCAS scores at each time based
on students’ responses regarding the extent to which they
had accomplished their ‘anxiety hierarchy’ task (0 = none
to 3 = complete) However, looking at the change in
the score at each stage, we found that the students who
reported positive progress in their responses to the item
on the extent to which they were able to accomplish their
anxiety hierarchy gradual exposure task also exhibited a
decrease in SCAS scores at the post-test and follow-up
test In contrast, the scores of students who reported
that they had not been able to complete any of the steps
toward their task were reduced in the post-test, but
sub-sequently increased again in the follow-up test
As a second point, when examining total scores in the
pre-test, we noticed that the higher the participant’s
anx-iety score, the lesser the extent to which they were able
to accomplish their anxiety hierarchy task The results
of many tests of CBT treatments for anxiety problems in
children and adolescents have shown that success with
exposure therapy is important to alleviate anxiety [47],
but the present study indicated that participants’ degree
of exposure achievement was lower among students with
higher anxiety scores Therefore, it is conceivable that
students with higher anxiety scores may not have been
able to set feasible targets that matched their anxiety
level (meaning that it was difficult for them to accomplish
the exposure task in their daily lives) In the future, it may
be necessary to improve the programme workbook,
espe-cially in relation to how to set a reasonable goal so that
students can select achievable targets that match their
individual capacities in class Assistance for students with
high anxiety who experience difficulty with gradual
expo-sure will also lead to the provision of early intervention
and support at school, which will be very helpful to such
students
Limitations and future prospects
There were several methodological problems and limi-tations with the present study, as follows First, because this was a pilot study, the number of participants may have been insufficient The study enabled the calculation
of sample size to detect clinically significant differences
in outcome measures Using the PS Power and Sample Size Calculator Software version 3.1.2 with α equivalent
to 05 and power (1−β) of 80, the required sample size for this type of research was found to be 200 participants each for the intervention and control groups [48] Addi-tionally, in this study, the anxiety scale (SCAS) scores dif-fered significantly between the intervention and control groups, possibly due to differences in grade between the students in these groups In the future, we aim to verify the efficacy of the programme by recruiting intervention and control groups with an appropriate number of par-ticipants from the same academic year
Next, according to systematic reviews and meta-anal-yses of school-based anxiety and depression prevention programmes, the effect size of such preventive pro-grammes is small, but it has been indicated that, even with a small effect size, there is a possibility that it can
be useful for preventing the onset of these disorders in youth [19] Additionally, research reports that young people (aged 7–14 years) with anxiety commonly worry about how others perceive them, and thus tend to give socially desirable responses instead of providing valid self-report [49] In the future, in order to evaluate the effects of preventive programmes, it will be necessary not only to evaluate efficacy using questionnaires (i.e., self-report), but also to design a long-term study in which a follow-up study of participants’ changes in anxiety score and the number of school refusals is conducted
Conclusions
Following the delivery by classroom teachers of the univer-sal anxiety prevention programme ‘Journey of the Brave’ for junior high school students in Japan, the feasibility
of the programme implementation in junior high school was partially confirmed However, there was no signifi-cant reduction in anxiety scores such as observed follow-ing implementation of the same programme in elementary schools This pilot study represented the first attempt to have classroom teachers deliver this programme and to use the programme with junior high school students Going forward, in consideration of the results and of the nature
of junior high school classes, we intend to improve the effi-cacy of the programme for this age group by modifying the workbook and number of session as well as by providing more detailed and structured teacher supervision In addi-tion, as there were several limitations to the design of this study, it will be necessary to test the feasibility and efficacy